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FDA 510(k)

Modus Nav

K-Number: K183325 · 2019-07-14

ApplicantSynaptive Medical, Inc.
Decision Date2019-07-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Modus Nav is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2019-07-14 under 510(k) number K183325. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modus Nav?

Modus Nav is a medical device that received FDA 510(k) clearance on 2019-07-14. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K183325.

When did Modus Nav receive FDA 510(k) clearance?

Modus Nav received FDA 510(k) clearance on 2019-07-14, under 510(k) number K183325.

Who is the listed applicant for Modus Nav?

The FDA 510(k) record lists Synaptive Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modus Nav?

The FDA product code for Modus Nav is HAW.

Other records listing Synaptive Medical, Inc. as applicant

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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